An interventional study of Early mobilization protocol and Standard care in Early Ambulation, Standard of Care and Subarachnoid Hemorrhage, Aneurysmal, sponsored by University of Pecs. Recruiting at 3 sites in Hungary. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2024-05-31.
Sponsored by University of Pecs · Not applicable, Interventional, and Treatment
The goal of the randomized clinical trial is to examine the effect of early mobilization on primary and secondary outcomes in patients with subarachnoid hemorrhage caused by aneurysm rupture.
Researchers will compare early mobiliziation vs. standrad bed rest care.
509 studies on the registry are indexed under Subarachnoid Hemorrhage; 124 are open to participants now.
This study's planned enrollment of 50 is close to the median of 52 across 263 interventional studies indexed under Subarachnoid Hemorrhage.
Browse Subarachnoid Hemorrhage studies →University of Pecs is the lead sponsor of 100 studies on the registry; 24 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
This group is mobilized in the intensive care unit by the institutional physiotherapist with the assistance of specialized personnel. Mobilization is carried out according to the Early Mobilization Protocol (EMP) Early mobilization protocol: * Step 1 - Day 1: Bed rest, elevation of the head end to 30° * Step 2 - Day 2: Bed rest, elevation of the head end to 60° * Step 3 - Day 3: Bed rest, elevation of the head end to 80° * Step 4 - Day 4: Sitting on the edge of the bed * Step 5 - Day 5: Sitting in a chair, standing up * Step 6 - Day 6: Walking with or without assistance * Step 7 - Day 7: Walking with or without assistance from today
Behavioral: Early mobilization protocol
No early mobilization
Behavioral: Standard care
* Step 1 - Day 1: Bed rest, elevation of the head end to 30° * Step 2 - Day 2: Bed rest, elevation of the head end to 60° * Step 3 - Day 3: Bed rest, elevation of the head end to 80° * Step 4 - Day 4: Sitting on the edge of the bed * Step 5 - Day 5: Sitting in a chair, standing up * Step 6 - Day 6: Walking with or without assistance * Step 7 - Day 7: Walking with or without assistance from today
During standard care, early mobilization does not take place in the intensive care unit; the patient receives only standard supportive care in bed rest.
Disability in early mobilization group (EM) vs. standard care group (SC) - modified Rankin score
Outcome assessments will include: Modified Rankin Scale Disability is assessed by the modified Rankin Scale, dichotomized at a score of 0 to 3 versus 4 to 6 (6=death).Assessment is performed by a blinded investigator of the local study center by personal visit.
Time frame: 14 day; 3 months
Disability in early mobilization group (EM) vs. standard care group (SC) - Extended Glasgow Outcome Scale
Extended Glasgow Outcome Scale Description of the neurological outcome by using extended Glasgow Outcome Score 1. Death 2. Vegetative sate 3. Lower severe disability 4. Upper severe disability 5. Lower moderate disability 6. Upper moderate disability 7. Lower good recovery 8. Upper good recovery Assessment is performed by a blinded investigator of the local study center by personal visit.
Time frame: 14 day; 3 months
Onset of delayed cerebral ischemia (DCI)
Occurence of DCI after aneurysmal subarachnoid hemorrhage
Time frame: 3-21 days
Onset of severity of macrovascular vasospasm
based on cerebral vasospasm grade Grade 0 All intracranial vessels show a physiological shape Grade 1 Vasospasm affects the A2, A1, and M2 segments Grade 2 Vasospasm expands to the M1 and terminal segment of the internal carotid artery Grade 3 Severe reduction in the intradural internal carotid artery with filiform A1 and M1 segments, which sometimes appears like a ghost (ghost sign)
Time frame: Up to 14 days
Stay in the Intensive Care Unit (ICU)
Length of stay in the Intensive Care Unit (ICU)
Time frame: Up to 28 days
Type of post-hospital discharge placement
home discharge, rehabilitation, chronic care, etc.
Time frame: Up to 30 days
Readmission to the ICU
repeated ICU treatment following ward discharge
Time frame: Up to 30 days
Occurrence of infection and its time in the intensive care unit
infection and its time in the intensive care unit
Time frame: Up to 30 days
Barthel score
For assessing activities of daily living in patients with aneurysmal subarachnoid hemorrhage; ordinal scale rates bowel function, bladder function, grooming, toilet use, feeding independence, transfer independence, mobility, dressing ability, stair use, and bathing ability to tabulate a composite score ranging from 0 to 100. Score of 100 represents totally independent. Assessment is performed by a blinded investigator of the local study center by personal visit.
Time frame: 14 day; 3 months
Functional Independence Measure (FIM) scale
The FIM's assessment of degree of disability depends on the patient's score in 18 categories, focusing on motor and cognitive function. Each category or item is rated on a 7-point scale (1 = \<25% independence; total assistance required, 7 = 100% independence) Assessment is performed by a blinded investigator of the local study center by personal visit.
Time frame: 14 day
Montreal Cognitive Assessment (MoCA)
MoCA scores range between 0 and 30. The MoCA is used for assessment for detecting cognitive impairment. A score of 26 or over is considered to be normal. Assessment is performed by a blinded investigator of the local study center by personal visit.
Time frame: 14 day; 3 months
Hospital Anxiety and Depression Scale (HADS)
Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 and 21 for either anxiety or depression. Items are rated on a 4-point severity scale. The HADS produces two scales, one for anxiety (HADS-A) and one for depression (HADS-D), differentiating the two states. Scores of greater than or equal to 11 on either scale indicate a definitive case. Assessment is performed by a blinded investigator of the local study center by personal visit.
Time frame: 14 day; 3 months
Plan to share: Yes — Investigators will use external resources for an appropriate repository for their data
Supporting information: Study protocol, Sap
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